Kentucky Plaintiff Files Lawsuit Against AstraZeneca, Bristol-Myers Squibb Claiming Kombiglyze XR Heart Damage

Published on September 10, 2018 by Sandy Liebhard

A woman from Kentucky has become one of the most recent plaintiffs to file suit against AstraZeneca and Bristol-Myers Squibb for heart damage allegedly caused by saxagliptin, the active ingredient in Onglyza and Kombiglyze XR.

Kombiglyze XR Allegations

According to a Kombiglyze XR lawsuit filed in the U.S. District Court, Eastern District of Kentucky, on August 22^nd, Wilma Sexton began taking the Type 2 diabetes drug in July 2018. She went on to develop serious complications, including heart failure, congestive heart failure, and cardiovascular injury, which Sexton clams were a direct and proximate result of her treatment with saxagliptin. (Case No.: 5:18-cv-00510-KKC)

“At all relevant times, Defendants had knowledge that there was a significant increased risk of adverse events associated with saxagliptin including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge Defendants continued to manufacture, market, distribute, sell, and profit from sales of saxagliptin,” the complaint states.

“Despite such knowledge, Defendants knowingly, purposely, and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers, and the public of the increased risk of serious injury associated with using saxagliptin including, but not limited to, heart failure, congestive heart failure, cardiac failure, and death related to those events,” the lawsuit continues.

Wexton seeks compensatory damages for medical bills and other losses, as well as punitive damages for what she claims was the defendants’ “knowing, reckless, conscious, wanton, willful, and deliberate disregard for the value of human life and the rights and safety of consumers.”

FDA Orders Heart Failure Warnings for Saxagliptin

Saxagliptin was developed jointly by AstraZeneca and Bristol-Myer’s Squibb.

The U.S. Food & Drug Administration (FDA) approved Onglyza (saxagliptin) in 2009. Kombiglyze XR (saxagliptin and metformin) was cleared for sale the following year.

The FDA launched a review of all saxagliptin-containing Type 2 diabetes medications in February 2014, after interim data from a large clinical trial called SAVOR-TMI indicated that patients treated with the medication were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.

A year later, an FDA advisory committee overwhelmingly voted to recommend that the prescribing information for all saxagliptin-containing medications be modified to warn of a potential heart failure risk. Heart failure warnings were finally added to the Kombiglyze XR and Onglyza labels in April 2016.

Since then, hundreds of plaintiffs have filed Onglyza and Kombiglyze lawsuits that accuse AstraZeneca and Bristol-Myers Squibb of concealing the heart risks associated with saxagliptin. The majority of these claims – at least 208 – are pending in the U.S. District Court, Eastern District of Kentucky, where all such federal lawsuits have been centralized for coordinated discovery and other pretrial proceedings.